FDA 510(k)

骨盆底練習器（PF01）

K 號：K252748 · 2026-04-27

申請人Hunan Accurate Bio-Medical Technology Co., Ltd.

決定日期2026-04-27

產品代碼HIR

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Pelvic Floor Exerciser (PF01) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-27 under 510(k) number K252748. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pelvic Floor Exerciser (PF01)?

Pelvic Floor Exerciser (PF01) is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. The 510(k) number is K252748.

When did Pelvic Floor Exerciser (PF01) receive FDA 510(k) clearance?

Pelvic Floor Exerciser (PF01) received FDA 510(k) clearance on 2026-04-27, under 510(k) number K252748.

Who is the listed applicant for Pelvic Floor Exerciser (PF01)?

The FDA 510(k) record lists Hunan Accurate Bio-Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvic Floor Exerciser (PF01)?

The FDA product code for Pelvic Floor Exerciser (PF01) is HIR.

其他以 Hunan Accurate Bio-Medical Technology Co., Ltd. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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